AI Representative
Non-EU-based organisations placing AI systems within the European market must appoint an authorised representative for their operations in the EU. iliomad health Data bridges the regulatory gap between your organisation and European competent authorities, ensuring continuous compliance with the EU AI Act obligations.
Becoming Compliance with the EU AI Act
The EU AI Act requires non-EU organisations deploying AI systems in Europe to appoint an EU-established authorised representative. As your EU AI Representative, iliomad Health Data serves as your official point of contact with EU authorities, maintaining technical documentation, managing regulatory communications, and supporting incident reporting ensuring your AI systems can be deployed lawfully and confidently across the EU.
We serve as your formal, designated point of contact with all EU supervisory authorities responsible for AI Act enforcement handling inquiries, providing information, and managing regulatory interactions on your behalf. When authorities request information about your AI systems, conduct inspections, or initiate enforcement procedures, we coordinate responses professionally and efficiently, protecting your interests while maintaining constructive regulatory relationships. Our team understands the procedures, expectations, and communication preferences of relevant authorities, enabling effective representation throughout the regulatory relationship.
We maintain, update, and make available your technical documentation as required by Annex IV of the AI Act,ensuring this critical compliance documentation accurately reflects your AI systems' design, development, capabilities, and limitations. We help you maintain documentation that meets regulatory requirements , ensuring you are always prepared for regulatory requests.
We provide proactive monitoring of regulatory developments affecting your AI systems, alerting you to interpretive guidance, enforcement actions, and regulatory changes that may affect your compliance obligations. The AI regulatory landscape is evolving rapidly, with implementing acts, delegated acts, and guidance documents continuing to elaborate AI Act requirements. We track these developments, assess their implications for your AI systems, and provide timely advice on any changes needed to maintain compliance.
Acting as your AI Authorised Representative, we verify that the EU declaration of conformity has been duly drawn up and that the appropriate conformity assessment procedure has been carried out. We ensure that your high-risk AI systems are supported by complete, consistent, and audit-ready conformity documentation in line with the EU AI Act
We cooperate with competent authorities in any regulatory actions relating to your high-risk AI systems, including measures aimed at reducing or mitigating identified risks. Where applicable, we also fulfil AI system registration obligations or verify the accuracy of registration information, ensuring that your systems are correctly represented in EU-level records.
We provide proactive monitoring of regulatory developments affecting your AI systems alerting you to interpretive guidance, enforcement actions, and regulatory changes that may affect your compliance obligations. The AI regulatory landscape is evolving rapidly, with implementing acts, delegated acts, and guidance documents continuing to elaborate AI Act requirements. We track these developments, assess their implications for yourAI systems, and provide timely advice on any changes needed to maintain compliance.
How iliomad Health Data Can Help You
iliomad has assisted healthcare companies in crafting AI models for various purposes, such as diagnosis, monitoring, and imaging. The experts at iliomad can guide you in pinpointing the kind of AI model you're creating, evaluating potential risks, determining responsibilities, and formulating a strategy to develop and launch your models in a compliant manner.
FAQs
Our frequently questions
An EU AI Act Representative is a legally mandated EU-established contact point for organizations outside the EU that deploy AI systems in Europe, required under the EU AI Act for non-EU providers of high-risk AI systems. The EU AI Representative serves as your official interface with EU supervisory authorities, maintains technical documentation, manages regulatory communications, and supports incident reporting to ensure lawful AI deployment across the EU.
Non-EU organizations must appoint an EU AI Representative if they deploy high-risk AI systems in the European Union, including medical devices with AI components, clinical decision support tools, diagnostic algorithms, patient risk stratification systems, or any AI system classified as high-risk under the EU AI Act. Most non-EU health tech, MedTech, and pharma companies using AI in European markets require this representative regardless of where their organization is established.
As your EU AI Representative, we serve as your EU-established point of contact for supervisory authorities, maintain and manage technical documentation, support conformity assessments and CE marking processes, handle incident reporting and regulatory notifications, provide post-market monitoring support, and deliver regulatory change monitoring and updates. With AI compliance experience across 66 countries, we ensure your EU AI Representative function meets the evolving requirements of the EU AI Act while coordinating with medical device, data protection, and other applicable regulatory frameworks.
We establish AI governance frameworks, conduct conformity assessments, perform periodic AI audits and performance reviews, ensure transparency and explainability requirements are met, define accountability structures and role definitions, maintain continuous compliance oversight, and interface with regulators and notified bodies. With AI compliance experience across 66 countries, we navigate the intersection of EU AI Act, medical device regulations (MDR/IVDR), GDPR, and FDA AI/ML requirements for health applications.
Contact us through our website form or email directly. We'll schedule an initial consultation to understand your regulatory landscape, identify immediate priorities, and propose a tailored engagement that fits your timeline and budget.
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